Peer-reviewed publication in New England Journal of Medicine validates findings first announced in December
The New England Journal of Medicine (NEJM) has published final results of a nationwide multicenter study led by researchers at Johns Hopkins Medicine and the Johns Hopkins Bloomberg School of Public Health that show plasma from patients who have recovered from COVID-19 and whose blood contains antibodies against SARS-CoV-2, the causative virus, is an effective and safe option as an early outpatient treatment for the disease. Luminis Health Anne Arundel Medical Center was one of twenty-two academic medical centers nationwide that participated in the study.
The research showed that antibody-rich COVID-19 convalescent plasma —collected from recovered patients and administered to COVID-19 outpatients within nine days after testing positive — reduced the need for hospitalization by more than half. The U.S. Food and Drug Administration (FDA) currently authorizes this plasma as a treatment option for inpatients and outpatients with immunocompromised status.
“Based on our findings and conclusions — which are now validated through the peer-review process — we encourage health care professionals to keep SARS-CoV-2 antibody-rich blood plasma available in their blood banks as part of the treatment arsenal against early-stage COVID-19,” says study co-lead author David Sullivan, M.D., professor of molecular microbiology and immunology at the Johns Hopkins Bloomberg School of Public Health with a joint appointment in infectious diseases at the Johns Hopkins University School of Medicine. “We believe that the best role for convalescent plasma is extending its use to early outpatient treatment when other therapies, such as monoclonal antibodies or drugs, are either not readily available — as in low- and middle-income countries — or ineffective, as with SARS-CoV-2 variants that are resistant to certain monoclonal antibodies,” Sullivan adds.
“The research team at Luminis Health Anne Arundel Medical Center (LHAAMC) honors the patients involved in this study who are among the more than 400 patients at LHAAMC who have participated in research studies for COVID-19,” said Barry Meisenberg, M.D., chair of the department of medicine at Luminis Health Anne Arundel Medical Center and local principal investigator for the study. “Their voluntary participation has led the search for lifesaving therapies, not just for themselves, but for future patients all around the world.”
In the outpatient early-treatment study conducted between June 2020 and October 2021, the researchers provided 1,181 randomized patients with one dose each of either high antibody containing convalescent plasma (containing a concentrated mixture of antibodies specific to SARS-CoV-2) or placebo control plasma (with no SARS-CoV-2 antibodies). The patients were 18 and older, and had tested positive for SARS-CoV-2 within eight days prior to transfusion.
The study found that 17 patients out of 592 (2.9%) who received the convalescent plasma required hospitalization within 28 days of their transfusion, compared with 37 out of 589 (6.3%) who received placebo control plasma. This translated to a relative risk reduction for hospitalization of 54%. Patients treated within 5 days of the positive test appeared to have an even better outcome: reduction of 80% in the risk of hospitalization, similar to other authorized therapies.
The next step, the researchers say, is to make convalescent more accessible to those who might need it. As part of that effort, they have provided clinicians with a guide for implementing a plasma transfusion center for outpatients with COVID-19, including logistical, staffing and blood banking requirements.
The team also continues to seek more understanding of how convalescent plasma works. A soon-to-be published study will look at the ability of plasma to neutralize SARS-CoV-2 variants, including delta and omicron, despite no previous donor exposure to those viruses. You can read the pre-print manuscript here.